What needs fixing and how can we fix it?

The FDA doesn’t regulate in a vacuum. We need to listen to all our stakeholders – the American people who we protect and the industries we regulate. One important way we do this is by a process calledretrospective review of regulations.

So what does this mean? As part of a process begun by President Obama, the FDA today announced that we are formally asking for submissions on how to improve existing regulations. Retrospective reviews like this really help us focus on how we can improve our regulations and give us invaluable insights on how we, and those we regulate, can be more innovative and take advantage of innovation as we work to protect and promote the public health.

For FDA, review of regulations is grounded in straightforward principles. First, regulations should change with the times. Second, they should not impede innovation and, if possible, foster it. Third, the effort they call for (the burden or cost of complying) should be reasonable. Fourth, they should not be ineffective. In other words, regulations should make sense, and if they don’t, we should change, strengthen, clarify, streamline, or revoke them.

That’s where you come in.

We want to hear from you. Help us identify areas to focus and improve. Where are our regulations ineffective? Do our regulations address current public health challenges? Where do we need to update our regulations? Can we revise them in ways that makes them less burdensome without making them less effective? Where can we be more flexible? How we can put greater emphasis on innovative scientific approaches? Do we have regulatory requirements that are redundant, inconsistent or needlessly overlap?

We’re most interested in big ideas, ones that identify regulatory problems that have the greatest impact on the public health.

If you want to help us with this important task, you can learn more by visiting the Federal eRulemaking Portal and following the instructions for submitting comments.

We are looking forward to your suggestions. Thank you very much – Leslie

This effort to review existing regulations is commendable and has the potential to be very beneficial. I would suggest, however, that this undertaking is handled in a way that is similar to “Phase II: Public Disclosure” of the Transparency Initiative in that suggestions are made, FDA proposals are shared, and public comment is asked for on those proposals before final decisions are made.

The reason that I urge this is that I have observed on other dockets that formal comments are often submitted at the last moment before the deadline. This may provide some strategic advantage to certain stakeholders in having their voice heard loudly and in giving their “opposition” little or no time to respond, but this process does not necessarily result in the best regulations being formed.

This initiative may have far reaching consequences, and it is impossible to predict the types of suggestions that will be made. As a consumer, I do not want protections stripped away without adequate time to consider and comment on the proposed regulation changes.

I don’t know what the regulations are regarding advertising of drugs on television, billboards and magazines but it seems to me that individuals (especially the younger ones) are more and more becoming unduly influenced and/or targeted by drug companies. WHEN did drug companies start ‘enticing’ children with ipods, gift cards, and REBATES (Merck has done this … http://www.gardasilrebate.com/) to use their medical products? And when did parental consent suddenly become a thing of the past (http://www.yourspine.com/Chiropractic/HPV+Vaccine+Parental+Consent.aspx) If DOCTORS are the ones that are ‘supposed’ to be providing ‘expertise’ for their clients, why would the FDA allow this to happen? In Europe, drug advertising is banned. Perhaps they were concerned about the drug companies having too much power in advertising? Something to think about.

I also believe that the FDA needs to put more credence in their OWN SYSTEM of adverse events for drugs and vaccines that have already been approved (I am familiar with the VAERS system of reporting adverse events but admittedly don’t have knowledge of how adverse reactions from drugs like VIOXX are reported). Is this system in place solely ‘for looks’ so that WE THE PEOPLE are led to believe that someone actually monitors the system? If the FDA isn’t going to pay attention to the system currently in place that reports severe side effects, then why bother with the reporting system at all?

WILL ANYONE THAT CAN MAKE CHANGE READ THIS?! I would love to hear back from someone at the FDA.

One more idea for you FDA … how about transparency in how drug trials are performed? Since so many drug companies now perform their test trials OUTSIDE the USA because of cost containment issues, WE THE PEOPLE need to know how this impacts the efficacy of the drugs being approved for the majority of the US population. I’m certain I am oversimplifying, but for argument sake, let’s say that drug approval for ‘test population A’ should consider that this drug will only be given to the same genetic type as the population for which it is prescribed. For instance, drugs that are tested in population type A (I’ll use the example of Hispanics) needs to be given to patient type A (Hispanics). Drugs that are tested on population type B (Northern Europeans) should be given to similar patient type B (Northern Europeans). Since the drug companies have easy access to genetic information based upon bloodtype, and a variety of other genetic/DNA variants, then I argue that those variants should be considered in ALL test trials … or at the very least, they should be DISCUSSED PRIOR TO FDA APPROVAL (How would a person of population/genetic type A react to a drug tested in population/genetic type B).

I have first-hand knowledge that some drug companies do NOT include individuals of certain genotype (those with sickle-cell, auto-immune, etc.) in their reporting data when requesting FDA approvals and in fact, those individuals are PURPOSELY REMOVED from the data of the trials so as to skew the test results in the drug company’s favor. That means that the drug companies are selectively choosing which participants are included in their drug trials. I HIGHLY DOUBT THAT DOCTORS OR THE AMERICAN PEOPLE ARE AWARE THAT THIS IS A COMMON PRACTICE and I’m certain that the system was never intended to work that way. This type of practice puts certain individuals at a higher risk and I would argue that this is a form of blatant GENETIC DISCRIMINATION.

If the FDA is going to approve medications and vaccines, then the required testing should be conducted on a population similar to one receiving it, even if it is slightly more costly. If drug trials intentionally leave out specific segments of the population, then FULL DISCLOSURE is necessary PRIOR to a doctor prescribing or recommending it. I believe most individuals would agree with me that drug companies are intentionally cheating the system by eliminating those individuals from their data when asking for approval or expansion of new or existing drugs and the FDA advisory panels are complicit in allowing drugs to come to market that they already know will damage those individuals.

I’m really hoping this goes through and we can begin to see some serious improvement over the next couple of years. It’s really good for the government to look within itself and ask how it can improve!

As a consumer I would like and hope that you would insist on manufacturers having GMO done to their foods label the food somewhere in the front, so we could see it clearly so that we have a choice weather to buy the product or not, as for me i wouldnt as i just buy organic when i can…

Certainly there are many problems, much more then ones presented above, however they all have solutions as well. It is good to know that some are actually being worked on and are one step closer to fixing!

The regulations everyone is so happy about, are just one small step in limiting the powers of drug companies. Even if they will be implemented (which I doubt), there will always be a way to bypass it. It all comes down to money and whoever has more money has more influence, let’s face it. What we, the people, can do is being UNITED and PERSISTENT in our resolve to influence the drug companies, the lobbyers and politicians carrying out laws which put us in the lab rats’ position. This article is just one step into our declaration that we also have a power.

I agree with your concept. These drug companies have too much power; they can influence even the government policies. I believe that the FDA needs to put more credence in their Own System of adverse events for drugs and vaccines that have already been approved.

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December 15, 2011 at 8:20 pm

You are right the drug companies have too much power and for once I hate the laws regarding patents. This is the best place to start regulating I think.

I don;t know if my idea sounds realistic or nearly fantastic…But I think we DO need to mark food packaging like “dangerous for health” or something when the ingredients are not natural or healthy. This mostly refers to fastfood and grocery products. The idea with the green and red marks on the dishes in the army was great, however, I think only a verbal warning will actually work. It is like when we learn kids to cross the street when they see the green light and stop when the light is red. I understand food priducing and ….hmmm… drug comanies will never let it happen, but the bet is the health of our kids. And, at least, I tried to give voice to it.

I think the main area to improve it would be the efficiency. Less bureaucracy and faster and more effective results. I’ve noticed that over the passed couple of years one important area has had substantial improvement: transparency.

I am writing to express concern regarding the search features on the Government Printing Office webpage and FDA’s poor communication of how to comment during public comment periods. I was trying to find the Federal Register docket number for a Food & Drug Administration draft guidance document on clinical trials, Draft Guidance for Industry: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (August 2011). I attempted to find the document on the GPO site for 45 minutes to no avail. I knew the agency, I knew the month, I even knew the exact title of the draft guidance document.

Nothing but failure.

The FDA published the draft guidance without putting the docket number in the document for those of us who might want to comment. The Federal Register is indexed in a manner that is impossible to search. And I worked for FDA for 17 years (and 3 days) including in the San Francisco District Consumer Affairs Office assisting the public in navigating the government’s highways and byways. If I couldn’t find it then imagine the problems the general public would have. The FDA and GPO hid this document DEEP. Fortunately, an excellent FDA employee at the Center for Devices and Radiological Health responded to an email request for assistance.

FDA and other government agencies are publishing a lot of draft guidance documents and proposed rules. The public has a right to comment. The government has the responsibility to assist the public in commenting. By burying the process in a bureaucratic maze, FDA and the GPO are playing into the hands that say we don’t need food safety or safe and effective drugs.

I am requesting that the transparency blog ask FDA and the GPO what they are doing to de-mystify the rule making process and making it accessible to the general public. Crucial FDA protections are on the chopping block and FDA’s management is not being transparent to the public. Pretty outrageous.

This is a wonderful idea, it could do a lot of good and bring great change to the United States. However, with as great as an idea this is, I don’t truly believe that the FDA would actually take into benefit out own personal beliefs. This sounds like just another way to make Americans believe that they have the power, where as it is the government and always will be the government that has the final say.

I’m very happy to find this page. I need to to thank you for your time for this particularly wonderful read!! I definitely appreciated every little bit of it and I have you bookmarked to look at new stuff in your website.

It is always a delicate balance between regulations that are minimal and sometimes do not work and regulations that become burdensome then threaten the very industries and occupations that fall within them. That said, it is good to see an agency accepting new ideas and taking feedback from those whom it serves.

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